FINACEA Gel Ref.[8142] Active ingredients: Azelaic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Product name and form

Finacea 15 % Gel.

Pharmaceutical Form


White to yellowish-white opaque gel.

Qualitative and quantitative composition

1 g Finacea Gel contains 150 mg (15%) azelaic acid.

Excipients with known effect:

1 mg Benzoic acid /g Gel

0.12 g Propylene glycol /g Gel

For the full list of excipients, see section 6.1.

Active Ingredient Description
Azelaic acid

Azelaic Acid is a naturally occurring dicarboxylic acid. Azelaic acid possesses antibacterial, keratolytic, comedolytic, and anti-oxidant activity. Azelaic acid is bactericidal against Proprionibacterium acnes and Staphylococcus epidermidis due to its inhibitory effect on the synthesis of microbial cellular proteins.

List of Excipients

Benzoic acid (E210)
Disodium edetate
Polysorbate 80
Propylene glycol
Purified water
Sodium hydroxide
Triglycerides medium chain

Pack sizes and marketing

Aluminium tube with internal epoxide coating and polyethylene screw cap.

Tubes of 5, 30, 50, 2 × 50 g.

Not all pack sizes may be marketed.

Marketing authorization holder

LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Marketing authorization dates and numbers

PL 00043/0237



Drug Countries
FINACEA Austria, Canada, Estonia, Spain, France, Lithuania, Mexico, United Kingdom, United States

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